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U.S. Department of Health and Human Services

Class 3 Device Recall GranuFlo Dry Acid Concentrate

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 Class 3 Recall
GranuFlo Dry Acid Concentrate
see related information
Date Posted January 17, 2013
Recall Status1 Open
Recall Number Z-0680-2013
Recall Event ID 63768
Premarket Notification
510(K) Number
K030497 
Product Classification Dialysate Concentrate For Hemodialysis (Liquid Or Powder) - Product Code KPO
Product Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Information Lot Number:12NXGF009
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham, Massachusetts 02451-1521
Manufacturer Reason
for Recall
GranuFlo Dry Acid Concentrate may show discoloration
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Fresenius Medical Care North America notified consignees by telephone on November 26, 2012 and follow-up letter on November 30, 2012 of the product recall. On January 10, 2013, the firm expanded there recall to an additional 32 lots (34 lots total). Customers were instructed to examine their inventory immediately, discontinue use, place all units in quarantine and return to Fresenius Medical Care North America. Customers were advised to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. For questions contact the GranuFio Recall Line at 1-888-803-0509.
Quantity in Commerce 5 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE
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